Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
NCT ID: NCT00863460
Last Updated: 2019-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2008-10-03
2026-05-31
Brief Summary
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To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
MTX-based chemotherapy followed by WBRT
cranial radiotherapy
40 Gy
MTX based chemotherapy
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\&59 and days79\&80
B
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue
MTX based chemotherapy
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\&59 and days79\&80
Interventions
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cranial radiotherapy
40 Gy
intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue
MTX based chemotherapy
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\&59 and days79\&80
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All histological types of non-Hodgkin's lymphoma, except MALT
* Age \> 18 and \< 60 ans.
* Negative for HIV, HCV and HBV
* Written informed consent -
Exclusion Criteria
* Isolated intra-ocular lymphoma
* Previous history of indolent lymphoma
* Previous chemotherapy or radiotherapy for PCNSL
* Isolated CNS relapse of systemic NHL
* Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
* Renal insufficiency or creatinin clearance \< 60 ml/min
* Liver enzymes \> 3N.
* Platelets \< 100 000/mm3 or neutrophils \< 1500/mm3)
* Previous history of organ transplantation or other cause of severe immunodeficiency
* Pregnancy or active sexual women with no contraception
* Unable to follow the protocol for any reason
18 Years
60 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Hoffmann-La Roche
INDUSTRY
Amgen
INDUSTRY
Pierre Fabre Laboratories
INDUSTRY
Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Carole Soussain, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie - Hôpital René Huguenin
Locations
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Cancérologie Hôpital Sud
Amiens, , France
Chu D'Angers
Angers, , France
CHR Argenteuil
Argenteuil, , France
CHU de Besancon
Besançon, , France
Institut Bergonié
Bordeaux, , France
CHU Hôtel Dieu
Clermont-Ferrand, , France
CHU Michalon
Grenoble, , France
Centre Hospitalier Lens
Lens, , France
CHU de Limoges
Limoges, , France
CHU de la Timone
Marseille, , France
Hôtel Dieu Nantes
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHU de Nimes
Nîmes, , France
GH Pitié-Salpétrière
Paris, , France
CHG Saint Jean
Perpignan, , France
CHU Hôpital Bernard
Poitiers, , France
Chu Reims
Reims, , France
Hôpital Pontchaillou
Rennes, , France
Centre René Huguenin
Saint-Cloud, , France
Institut de Cancérologie
Saint-Priest-en-Jarez, , France
CH de Saint-Quentin
Saint-Quentin, , France
Hôpital Bretonneau
Tours, , France
CHU Nancy - Hôpital Neurologique
Vandœuvre-lès-Nancy, , France
Countries
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References
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Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.
Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20.
Other Identifiers
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EudraCT N° 2007-005378-30
Identifier Type: -
Identifier Source: secondary_id
CRH 07/422/H
Identifier Type: -
Identifier Source: org_study_id
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